510(k) K202478

Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares by Boston Scientific Corporation — Product Code FDI

K202478 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares". The FDA issued a decision of Substantially Equivalent on October 8, 2020. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.